Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate - Full Text View

Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate (Capspal)

This study is ongoing, but not recruiting participants.

First Received: October 20, 2009 Last Updated: October 29, 2009 History of Changes

Sponsor:	Pennington Biomedical Research Center
Collaborator:	Ajinomoto USA, INC.
Information provided by:	Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT00999297

Purpose

A 4 week intake of drug to find a natural substance that may modify energy balance and may enhance health in combination with lifestyle changes with possible decrease in body weight.

Condition	Intervention
Obesity Weight Control	Other: Dihydrocapsiate

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate: A Double-blind Randomized Parallel Arm Study

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:

The consumption of dihydrocapsiate will significantly increase resting energy expenditure and fat oxidation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	86
Study Start Date:	July 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sugar pill (Placebo o mg/d): Placebo Comparator 0 mg/d sugar pill	Other: Dihydrocapsiate Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
Dihydrocapsiate: Active Comparator Drug 3 mg/d or 9 mg/d including Placebo	Other: Dihydrocapsiate Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
3 mg/d or 9 mg/d Dihydrocapsiate: Active Comparator Drug including Placebo	Other: Dihydrocapsiate Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo

Detailed Description:

This study is a double-blind, placebo-controlled, single center, randomized, parallel arm clinical trial to test the impact of Dihydrocapsiate (placebo, 3 and 9 mg/d) ingested for 4 weeks on resting metabolic rate and fat oxidation measured by indirect calorimetry.

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Men between 20-60 years old
Healthy as assessed by medical history and standard medical exam
Weight-stable
Body mass index of 25 to 34.9 kg/m2
Non-smoker
Sedentary lifestyle: not being physically active grater than 3 days/week for 20 min each time for the previous 6 months, and not participating in regular resistance exercise.

Exclusion Criteria:

Subjects enrolled in a diet to increase or decrease body weight
Special diet or food aversiions to common foods
Has allergy to chilli pepper
Eating chilli peppers on a daily basis
Usually consuming more than 2 cups of tea or coffee/day
Usually consuming more than 4 cans of caffeinated soft drinks a day
Usually consuming more than 3 standard alcohol drinks/day
Regular use of medications (weight loss drugs, drugs affecting energy metabolism, drugs for depression)
Usual intake of illicit substances
Claustrophobia
Participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999297

Locations

United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70809

Sponsors and Collaborators

Pennington Biomedical Research Center

Ajinomoto USA, INC.

Investigators

Principal Investigator:

Eric Ravussin, PhD

Pennington Biomedical Research Center

More Information

No publications provided

Responsible Party:	Pennington Biomedical Research Center ( Eric Ravussin, PhD/Principal Investigator )
Study ID Numbers:	CAPSPAL, PBRC28016
Study First Received:	October 20, 2009
Last Updated:	October 29, 2009
ClinicalTrials.gov Identifier:	NCT00999297 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on February 08, 2010